DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 11-16 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12-16, 18-20, and 23 of U.S. Patent No. 11,819,698. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 7, 10, 11, 17, and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer et al (US Publication 2016/0015984) in view of Funke et al (US Patent 4,284,082).
Referring to Claims 1 and 21, Demmer et al teaches a medical device system/ non-transitory computer readable medium comprising: sensing circuitry configured to: sense one or more cardiac signals (e.g. Figure 3, Element 204); sense atrial event signals from the one or more cardiac signals (e.g. Figure 3, Element 222 and Paragraph [0064] discloses sensing NF P waves); pulse generating circuitry configured to deliver atrial pacing pulses based on the sensed atrial event signals (e.g. Figure 3, Element 202 and Figure 1, Element 12 and Paragraph [0060] discloses RA pacemaker 12 start at a lower rate pacing escape interval in response to an intrinsic sensed P-wave); control circuitry (e.g. Figure 3, Element 206) configured to: control the pulse generating circuitry to deliver the atrial pacing pulses based on the sensed atrial event signals (e.g. Paragraph [0055] discloses when pacemaker 100 is a RA pacemaker 12, control module 206 is enabled to self-configure the solo and duo operating modes of the RA pacemaker); determine a ventricular activity metric from the one or more cardiac signals (e.g. Figure 3, Element 224 and Paragraph [0064] discloses FF R-waves); based on the ventricular activity metric, determine an atrioventricular synchrony metric that represents the performance of a ventricular pacemaker in maintaining synchrony between ventricular pacing pulses delivered by the ventricular pacemaker and at least one of the sensed atrial event signals or the delivered atrial pacing pulses (e.g. Paragraph [0092] discloses an absence or latency of FF R-waves is an indication of the development of AV); generate an output based on the atrioventricular synchrony metric (e.g. Paragraph [0092] discloses data relating to evidence of AV block based on FF R-wave sensing is stored); a memory configured to store data corresponding to the atrioventricular synchrony metric in response to the output generated by the control circuit (e.g. Paragraph [0092] discloses data relating to evidence of AV block based on FF R-wave sensing is stored). However, Demmer et al does not disclose generate an output based on the atrioventricular synchrony metric by at least adjusting an atrial pacing control parameter based on the atrioventricular synchrony metric; and control the pulse generating circuitry according to the adjusted atrial pacing control parameter.
Funke et al teaches that it is known to generate an output based on the atrioventricular synchrony metric by at least adjusting an atrial pacing control parameter based on the atrioventricular synchrony metric; and control the pulse generating circuitry according to the adjusted atrial pacing control parameter as set forth in Column 3 lines 51-66 and Column 12 lines 7-19 to provide improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most (e.g. Column 4, lines 28-30). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Demmer et al, with generating an output based on the atrioventricular synchrony metric by at least adjusting an atrial pacing control parameter based on the atrioventricular synchrony metric; and control the pulse generating circuitry according to the adjusted atrial pacing control parameter as taught by Funke et al, since such a modification would provide the predictable results of improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most.
Referring to Claims 7 and 17, Demmer et al in view of Funke et al teaches the claimed invention further comprising: an atrial pacemaker (e.g. Figure 1, Element 12) comprising: a housing that encloses the sensing circuitry, the pulse generating circuitry and the control circuitry (e.g. Figure 2, housing 150 and Figure 3, Elements 204, 202, and 20 are within the housing 100 and Paragraph [0042] discloses electrodes are spaced apart along the housing); a first telemetry circuit configured to transmit data corresponding to the atrioventricular synchrony metric stored in the memory (e.g. Figure 3, telemetry 208); an external device (e.g. Figure 1, Element 20) comprising: a second telemetry circuit configured to receive the transmitted data (e.g. Paragraph [0078] discloses external device 20 includes telemetry to communicate with 208 of the pacemaker); a display unit configured to generate a display of at least a portion of the transmitted data in a user interface (e.g. Paragraph [0037] discloses external device 20 includes displays).
Referring to Claims 10 and 20, Demmer et al in view of Funke et al teaches the claimed invention further comprising: a first telemetry circuit configured to transmit data corresponding to the atrioventricular synchrony metric stored in the memory (e.g. Figure 3, telemetry 208); the ventricular pacemaker (e.g. Figure 1, element 14) configured to: receive the transmitted data (e.g. Paragraphs [0038] and [0092] discloses communicating when the other pacemaker is sensing cardiac events, evidence of AV block, is transmitted to the other pacemaker); adjust at least one of a sensing control parameter or a ventricular pacing control parameter in response to receiving the transmitted data (e.g. Paragraphs [0027], [0104], and [0105] discloses patients having AV conduction defects providing DDD(R) pacing).
Referring to Claim 11, Demmer et al teaches a method, comprising: sensing one or more cardiac signals (e.g. Figure 3, Element 204); sensing atrial event signals from the one or more cardiac signals (e.g. Figure 3, Element 222 and Paragraph [0064] discloses sensing NF P waves); generating atrial pacing pulses based on the sensed atrial event signals (e.g. Figure 3, Element 202 and Figure 1, Element 12 and Paragraph [0060] discloses RA pacemaker 12 start at a lower rate pacing escape interval in response to an intrinsic sensed P-wave); determining a ventricular activity metric from the one or more cardiac signals (e.g. Figure 3, Element 224 and Paragraph [0064] discloses FF R-waves); based on the ventricular activity metric, determining an atrioventricular synchrony metric that represents the performance of a ventricular pacemaker in maintaining synchrony between ventricular pacing pulses delivered by the ventricular pacemaker and at least one of the sensed atrial event signals or the delivered atrial pacing pulses (e.g. Paragraph [0092] discloses an absence or latency of FF R-waves is an indication of the development of AV); generating an output based on the atrioventricular synchrony metric (e.g. Paragraph [0092] discloses data relating to evidence of AV block based on FF R-wave sensing is stored); adjusting, by an implantable medical device, at least one of a sensing control parameter or a pacing control parameter in response to the generated output (e.g. Paragraphs [0093 and 0098] disclose inhibiting a scheduled atrial pacing pulse or adjusting atrial pacing pulse amplitude); storing data corresponding to the atrioventricular synchrony metric in response to the generated output (e.g. Paragraph [0092]). However, Demmer et al does not disclose generate an output by adjusting at least an atrial pacing control parameter based on the atrioventricular synchrony metric. Funke et al teaches that it is known to generate an output by adjusting at least an atrial pacing control parameter based on the atrioventricular synchrony metric as set forth in Column 3 lines 51-66 and Column 12 lines 7-19 to provide improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most (e.g. Column 4, lines 28-30). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Demmer et al, with generating an output by adjusting at least an atrial pacing control parameter based on the atrioventricular synchrony metric as taught by Funke et al, since such a modification would provide the predictable results of improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most.
Referring to Claim 22, Demmer et al in view of Funke et al teaches the medical device of claim 1, except wherein the control circuitry is further configured to adjust the atrial pacing control parameter by adjusting a timing of the atrial pacing pulses delivered by the pulse generating circuitry.
Funke et al teaches that it is known to adjust the atrial pacing control parameter by adjusting a timing of the atrial pacing pulses delivered by the pulse generating circuitry as set forth in Column 3 lines 51-66 and Column 12 lines 7-19 (atrial pacing rate) to provide improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most (e.g. Column 4, lines 28-30). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Demmer et al, with adjusting the atrial pacing control parameter by adjusting a timing of the atrial pacing pulses delivered by the pulse generating circuitry as taught by Funke et al, since such a modification would provide the predictable results of improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most.
Referring to Claim 23, Demmer et al in view of Funke et al teaches the method of claim 11, except further comprising adjusting the atrial pacing control parameter by adjusting a timing of the atrial pacing pulses. Funke et al teaches that it is known to adjust the atrial pacing control parameter by adjusting a timing of the atrial pacing pulses as set forth in Column 3 lines 51-66 and Column 12 lines 7-19 (atrial pacing rate) to provide improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most (e.g. Column 4, lines 28-30). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Demmer et al, with adjusting the atrial pacing control parameter by adjusting a timing of the atrial pacing pulses as taught by Funke et al, since such a modification would provide the predictable results of improved patient quality of life by providing the patient the full cardiac output of their heart when it is needed the most.
Allowable Subject Matter
Claims 8-9 and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights